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The goal of this study is to measure the test retest reliability of offset analgesia (OA) and onset hyperalgesia (OH) across multiple study visits. OA and OH are quantitative sensory tests (QST) thought to measure how the brain modulates pain. This study will use a heat thermode to induce OA and OH in healthy, pain-free volunteers across 3 study visits. Additional QST measures and survey data relevant to pain modulation will be collected. This study lays the foundation required to use OA and OH as tools to measure pain modulation in clinical trials. Following their validation, we anticipate that OA and OH will serve as predictive and therapeutic biomarkers, which will aid both in the development of novel analgesics and in treatment selection leading to the personalization of pain management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental | QST devices and computer tasks are used to measure OA, OH, pain intensity, and other outcomes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medoc cutaneous probe | Behavioral | A computer-controlled probe delivers temperatures to the skin to measure pain, OA, and OH |
|
| Measure | Description | Time Frame |
|---|---|---|
| Offset analgesia and onset hyperalgesia | Pain intensity difference during heat stimuli measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable) at baseline | baseline |
| Test retest reliability of offset analgesia and onset hyperalgesia | Pain intensity difference during heat stimuli measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable) at 1 week after baseline | 1 week post baseline |
| Test retest reliability of offset analgesia and onset hyperalgesia | Pain intensity difference during heat stimuli measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable) at 4 weeks after baseline | 4 weeks post baseline |
| Differences in brain region activation- QST (quantitative sensory tests) | Difference in brain region activation (as measured by oxygenated hemoglobin, HbO) between central nervous system inhibition and control stimuli during QST procedures. | baseline |
| Test retest reliability in brain region activation- QST (quantitative sensory tests) | Difference in brain region activation (as measured by oxygenated hemoglobin, HbO) between central nervous system inhibition and control stimuli during QST procedures at 1 week after baseline | 1 week post baseline |
| Test retest reliability in brain region activation- QST (quantitative sensory tests) | Difference in brain region activation (as measured by oxygenated hemoglobin, HbO) between central nervous system inhibition and control stimuli during QST procedures at 4 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in resting fNIRS signaling | Differences in fNIRS resting state connectivity as measured by brain region activation | baseline |
| Questionnaire score- State Trait Anxiety Inventory (STAI) Y1-2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benedict Alter, MD, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Pain Medicine at Centre Commons | Pittsburgh | Pennsylvania | 15206 | United States |
Individual participant data will be available, including data dictionaries, after publication per journal and funding protocols. The statistical analysis plan and analytic code will also be available per the same protocols.
Data will become available after publication per journal and funding entity protocols.
Data will be made available by reasonable request and/or per journal and funding entity protocols.
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Quantitative sensory testing | Behavioral | Standard methods involving pinprick, pressure, heat, and cold applied to the skin are used to measure sensation and pain |
|
| Computer tasks | Behavioral | QST and computer tasks are used to measure changes in pain intensity |
|
| 4 weeks post baseline |
Standardized survey score of state trait anxiety inventory Y1 and Y2 assessing anxiety before QST procedures on visit 1 only.
State Anxiety Score ranges from 20-80. Trait Anxiety Score ranges from 20-80. Higher scores indicate worse anxiety state and trait symptoms.
| baseline |
| Questionnaire score- Pain Catastrophizing Scale (PCS) | Standardized survey score assessing pain perception before QST procedures at visit 1 only. Rumination subscale score ranges from 0-16. Magnification subscale score ranges 0-12. Helplessness subscale score ranges from 0-24. Total score can be calculated by summing subscales. Total score ranges from 0-52, with higher scores indicating more pain catastrophizing. | baseline |
| Questionnaire score- STAI Y1 post testing | Standardized survey score of state trait anxiety inventory Y1 assessing anxiety immediately after QST procedures measured at all 3 visits. Higher scores indicate worse anxiety state. | baseline |
| Questionnaire score- STAI Y1 post testing | Standardized survey score of state trait anxiety inventory Y1 assessing anxiety immediately after QST procedures measured at all 3 visits. Higher scores indicate worse anxiety state. | 1 week after baseline |
| Questionnaire score- STAI Y1 post testing | Standardized survey score of state trait anxiety inventory Y1 assessing anxiety immediately after QST procedures measured at all 3 visits. Higher scores indicate worse anxiety state. | 4 weeks after baseline |
| Questionnaire score- Situational Pain Catastrophizing Scale post testing | Standardized survey score assessing pain perception immediately after QST procedures are completed at each visit. Scores range from 0-24, with higher scores representing more pain catastrophizing. | baseline |
| Questionnaire score- Situational Pain Catastrophizing Scale post testing | Standardized survey score assessing pain perception immediately after QST procedures are completed at each visit. Scores range from 0-24, with higher scores representing more pain catastrophizing. | 1 week after baseline |
| Questionnaire score- Situational Pain Catastrophizing Scale post testing | Standardized survey score assessing pain perception immediately after QST procedures are completed at each visit. Scores range from 0-24, with higher scores representing more pain catastrophizing. | 4 weeks after baseline |
| Questionnaire score- Beck Depression Inventory-II (BDI-II) | Standardized survey assessing depression at the start of visit 1. Scores range from 0-63. Total score of 0-13 is considered minimal range of depression, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression. | baseline |
| Questionnaire score- Generalized Anxiety Disorder 2-item (GAD-2) | Standardized survey score of GAD-2 assessing anxiety at the start of visit 1. Scores range from 0-6. Higher scores indicate higher likelihood of having GAD. | baseline |
| Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2 | Standardized survey score of MAIA-2 assessing mindfulness at the start of visit 1. Total scores range from 0-160 with 8 subscales. Higher scores indicate higher levels of mindfulness. | baseline |
| Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2 post testing | Standardized survey score of MAIA-2 assessing mindfulness after QST measured at all 3 visits. Total scores range from 0-160 with 8 subscales. Higher scores indicate higher levels of mindfulness. | baseline |
| Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2 post testing | Standardized survey score of MAIA-2 assessing mindfulness after QST measured at all 3 visits. Total scores range from 0-160 with 8 subscales. Higher scores indicate higher levels of mindfulness. | 1 week after baseline |
| Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2 post testing | Standardized survey score of MAIA-2 assessing mindfulness after QST measured at all 3 visits. Total scores range from 0-160 with 8 subscales. Higher scores indicate higher levels of mindfulness. | 4 weeks after baseline |
| Pain intensity | Changes in pain intensity during quantitative sensory tests and computer tasks measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable) | baseline |
| Pain intensity | Changes in pain intensity during quantitative sensory tests and computer tasks measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable) | 1 week after baseline |
| Pain intensity | Changes in pain intensity during quantitative sensory tests and computer tasks measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable) | 4 weeks after baseline |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |